FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RADIUS COUGAR WIRE
K Number: K032899
·
Decision Oct 17, 2003
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
9
Review Days
30
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Basic Information
- Device Name
- RADIUS COUGAR WIRE
- K Number
- K032899
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radius Medical Technologies, Inc.
- Date Received
- September 17, 2003
- Decision Date
- October 17, 2003
- Product Code
- DQX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | FDA class 2 | Cardiovascular |
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Other Clearances by Radius Medical Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K070502 | RADIUS SNARE | Oct 4, 2007 | Substantially Equivalent |
| K071457 | MODIFICATION TO RADIUS SNARE | Sep 25, 2007 | Substantially Equivalent |
| K032129 | RADIUS 018 COUGAR WIRE | Jul 17, 2003 | Substantially Equivalent |
| K022201 | RADIUS MICRO SNARE | Feb 3, 2003 | Substantially Equivalent |
| K021441 | RADIUS SNARE | Jun 14, 2002 | Substantially Equivalent |
| K011759 | RADIUS NEXT GENERATION GUIDEWIRE | Aug 23, 2001 | Substantially Equivalent |
| K011287 | RADIUS COUGAR WIRE | May 25, 2001 | Substantially Equivalent |
| K970466 | RADIUS PTCA GUIDEWIRE | May 20, 1997 | Substantially Equivalent |